Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial

Journal article
(Original article)


Publication Details

Author(s): Stingl J, Kaumanns K, Claus K, Lehmann ML, Kastenmüller K, Bleckwenn M, Hartmann G, Steffens M, Wirtz D, Lechs AK, Benda N, Meier F, Schöffski O, Holdenrieder S, Coch C, Weckbecker K
Journal: Bmc Family Practice
Publisher: BioMed Central
Publication year: 2016
Volume: 17
Journal issue: 49
ISSN: 1471-2296
Language: English


Abstract



Background



Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information leaflet with standard information on risk factors for side effects.





Methods/Design



The trial was designed as a prospective, two-arm, randomized, controlled, multicenter, pragmatic study. 960 elderly, multimorbid outpatients in general medicine are included if they take at least one high risk and one other long-term drug (polymedication). As high risk “index drugs” oral anticoagulants and antiplatelets were chosen because of their specific, objectively assessable side effects. Following randomization, test group patients receive an individualized risk assessment leaflet evaluating their personal data concerning bleeding- and thromboembolic-risk-scores, potential drug-drug-interactions, age, renal function and pharmacogenetic factors. Control group patients obtain a standardized leaflet only containing general information on these criteria. Follow-up period is 9 months for each patient. Primary endpoint is the occurrence of a thromboembolic/bleeding event or death. Secondary endpoints are other adverse drug reactions, hospital admissions, specialist referrals and medication changes due to adverse drug reactions, the patients’ adherence to medication regimen as well as health related quality of life, mortality and resulting costs.





Discussion



Despite extensive evidence of risk factors for adverse drug reactions, there are few prospective trial data about an individualized risk assessment including pharmacogenetic information to increase patient safety. By conducting a health economic analysis, we will evaluate if the application of an individualized drug therapy in daily routine is cost-effective.




 



FAU Authors / FAU Editors

Meier, Florian Prof. Dr.
Lehrstuhl für Betriebswirtschaftslehre, insbesondere Gesundheitsmanagement
Schöffski, Oliver Prof. Dr.
Lehrstuhl für Betriebswirtschaftslehre, insbesondere Gesundheitsmanagement


How to cite

APA:
Stingl, J., Kaumanns, K., Claus, K., Lehmann, M.-L., Kastenmüller, K., Bleckwenn, M.,... Weckbecker, K. (2016). Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial. Bmc Family Practice, 17(49). https://dx.doi.org/10.1186/s12875-016-0447-6

MLA:
Stingl, Julia, et al. "Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial." Bmc Family Practice 17.49 (2016).

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Last updated on 2018-19-04 at 03:32